What is the purpose of this study?
CIT-HD is a clinical trial designed to evaluate the effect of citalopram (also known as Celexa) compared to a placebo (an inactive substance) on attention, thinking ability, muscle movements and daily activities (such as working) in participants with Huntington’s disease.
Why citalopram?
Based on research using mice, citalopram may help improve cognition (thinking skills) in patients with Huntington’s disease. No human research has attempted to replicate these findings but, because citalopram is already FDA approved for the treatment of depression, it is a strong candidate for use in a Huntington’s disease clinical trial such as this one.
Who is eligible for this study?
Eligible participants must have tested gene positive for Huntington’s disease or have received a clinical diagnosis of Huntington’s disease. Participants must be between ages 18-65 and notice a change in their level of attention, focus and/or thinking ability. Eligible participants must provide written informed consent before any study activities can begin.
Individuals with major depression or, who are currently taking medication for depression, are not eligible for this study. Women who are pregnant, nursing, or planning to become pregnant during the study are also not eligible.
What will the study consist of?
This is a 20-week study. Participants will complete up to nine visits and up to three telephone visits. A screening visit will confirm that you are able to continue with the study. A blood sample will be taken at the screening visit for general health screening, and you may be given an MRI scan at subsequent visits.
For the duration of the study, you will be asked to take a 20-mg tablet each day. You will be randomly assigned (like a coin flip) to receive either citalopram or a look-alike drug with no active ingredients (a placebo). You will not know which tablet you have been assigned. However, we have access to this information for safety purposes or in an emergency.
During visits, you will be given thinking tests and motor examinations. We will also ask questions to assess your mood and mental functioning.
What are the benefits and/or risks of participating?
While we cannot be sure if you will directly benefit from participating in the study, your participation may help us evaluate a potential treatment for Huntington’s disease. This is important, as no medications are currently approved to treat the cognitive (thinking type) symptoms often reported by individuals with Huntington’s disease.
There are some risks when blood is drawn, and some individuals can become uncomfortable inside an MRI scanner (due to the confined space). The side effects associated with the use of citalopram are mild and will be fully discussed during the Screening Visit.
What is citalopram?
Citalopram (Celexa) is an FDA approved medication for the treatment of depression. It has not, however, been approved by the FDA for treatment of Huntington’s disease.
Will I be compensated? What about travel?
Participants will receive compensation for their participation in the study. We will also reimburse reasonable travel costs to/from the research center
Where can I participate?
Three academic-medical centers are enrolling participants:
- The University of Iowa in Iowa City, IA
- The University of Rochester in Rochester, NY
- Mayo Clinic Arizona in Scottsdale, AZ
Who do I contact for more information about CIT-HD?
If you are interested in participating or would like more information, please contact:
William H. Adams, B.A.
Senior Clinical Trials Coordinator
Research Assistant to Dr. Leigh J. Beglinger
The University of Iowa
Carver College of Medicine
Department of Psychiatry
2-103 Medical Education Building
Iowa City, IA 52242
Office: (319) 353-4411
Email: william-h-adams@uiowa.edu
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